| Primary | Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8 | ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score. | ITT population included all participants who were randomized and received study drug. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Day 8 | | | | ID | Title | Description |
|---|
| OG000 | AN2728 Ointment 0.5 Percent, Once Daily | AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. | | OG001 | AN2728 Ointment 2 Percent, Once Daily | AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. | | OG002 | AN2728 Ointment 0.5 Percent, Twice Daily | AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator. | | OG003 | AN2728 Ointment 2 Percent, Twice Daily | AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator. |
| | Units | Counts |
|---|
| Participants | - OG00044
- OG00144
- OG00242
- OG003
|
| | Title | Denominators | Categories |
|---|
| Baseline | | | Title | Measurements |
|---|
| - OG0008.22± 1.891
- OG0018.02± 1.852
- OG0028.13± 1.811
- OG003
|
|
| |
| Primary | Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15 | ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score. | ITT population included all participants who were randomized and received study drug. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Day 15 | | | | ID | Title | Description |
|---|
| OG000 | AN2728 Ointment 0.5 Percent, Once Daily | AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. | | OG001 | AN2728 Ointment 2 Percent, Once Daily | AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. |
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| Primary | Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22 | ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score. | ITT population included all participants, who were randomized and received study drug. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Day 22 | | | | ID | Title | Description |
|---|
| OG000 | AN2728 Ointment 0.5 Percent, Once Daily | AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. | | OG001 | AN2728 Ointment 2 Percent, Once Daily | AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. |
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| Primary | Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29 | ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score. | ITT population included all participants who were randomized and received study drug. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Day 29 | | | | ID | Title | Description |
|---|
| OG000 | AN2728 Ointment 0.5 Percent, Once Daily | AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. | | OG001 | AN2728 Ointment 2 Percent, Once Daily | AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. |
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| Secondary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion. | Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to Day 29 | | | | ID | Title | Description |
|---|
| OG000 | AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily | AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. | | OG001 | AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily | AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator. |
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| Secondary | Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Clinical significance of laboratory parameters was determined at the investigator's discretion. | Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to Day 29 | | | | ID | Title | Description |
|---|
| OG000 | AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily | AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. | | OG001 | AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily | AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator. |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study treatment (Day 29), that were absent before treatment or that worsened relative to pre-treatment state. | Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to Day 29 | | | | ID | Title | Description |
|---|
| OG000 | AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily | AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. | | OG001 | AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily | AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator. |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events By Severity | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function. Number of participants with mild, moderate and severe treatment-emergent AEs were reported in this outcome measure. | Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to Day 29 | | | | ID | Title | Description |
|---|
| OG000 | AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily | AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. | | OG001 | AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily | AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator. |
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| Secondary | Number of Participants With Local Tolerability Symptoms | Participants who experienced local tolerability symptoms: mild itching or burning/stinging at sites of study drug application were reported in this measure. | Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to Day 29 | | | | ID | Title | Description |
|---|
| OG000 | AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily | AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. | | OG001 | AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily | AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator. |
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| Secondary | Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29 | ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from baseline was calculated as baseline evaluation minus the follow-up evaluation. | ITT population included all participants who were randomized and received study drug. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Day 8, 15, 22, 29 | | | | ID | Title | Description |
|---|
| OG000 | AN2728 Ointment 0.5 Percent, Once Daily | AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. | | OG001 | AN2728 Ointment 2 Percent, Once Daily | AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator. |
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